HeartStitch

HeartStitch has developed and commercialized minimally invasive suture-based medical devices for the treatment of structural heart defects such as PFO and ASD. Its flagship product NobleStitch EL has demonstrated safety and efficacy comparable to or better than traditional umbrella devices in multicenter studies. The company’s TA and MR systems are FDA cleared for vascular suturing; the trans-apical access device holds CE Mark approval. Over several hundred patients have been treated globally with positive outcomes reported from European centers. The company continues to expand its product line into mitral/tricuspid interventions.